Phase 4
N=659
BCG Vaccine for Health Care Workers as Defense Against COVID 19
Coronavirus · Coronavirus Infection · Coronavirus as the Cause of Diseases Classified Elsewhere
Bottom Line
View on ClinicalTrials.gov: NCT04348370 ↗Enrolled (actual)
659
Serious AEs
0.2%
Results posted
Oct 2024
Primary outcome: Primary: Number of New COVID 19 Infections — 25; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BCG Vaccine (Biological); Placebo Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas A&M University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of New COVID 19 Infections |
25; 21 | — |
| SECONDARY Disease Severity |
2; 2 | — |
Summary
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years)
- Male or female
- Hospital personnel taking care for patients with known or suspected SARS-CoV-2 infection and providing, on average, at least 25 hours per week of direct patient care
Exclusion Criteria
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
- Fever (>38 C) within the past 24 hours
- Age > 75 years
- Pregnancy or planning pregnancy within 30 days of study enrollment
- Breastfeeding
- Suspicion of active viral or bacterial infection
- Any Immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with known neutropenic with less than 1500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) known severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Living with someone who is immunosuppressed or taking immunosuppressive drugs
- Previous documented infection with COVID19
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Direct involvement in the design or the execution of the study
- Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
- Not in possession of a smartphone
- Inability to keep the vaccine site covered in the case of a draining pustule.
Data sourced from ClinicalTrials.gov (NCT04348370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.